MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP; MITRAL VALVE REPAIR DEVICES

Model Number	CDS0701-NTW
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	09/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported incomplete coaptation.Additionally, a review of the complaint history identified did not indicate a lot-specific quality issue.Based on available information, the reported incomplete coaptation is related to challenging patient anatomy (connective tissue disease).The reported heart failure and mitral regurgitation are cascading events of the incomplete coaptation.The reported patient effects of heart failure and mitral regurgitation, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization and unexpected medical intervention were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported on (b)(6) 2025 that the patient presented with grade 4 degenerative mitral regurgitation (mr) and prolapsed posterior leaflet for a mitraclip procedure.During the procedure, 2 mitraclips were successfully implanted.On an unknown date the patient was hospitalized for heart failure.It was discovered that the second clip had single leaflet device attachment(slda).The clip detached from the posterior leaflet.Per the physician, slda was due to connective tissue disease.Recurrent mr of grade 4 was reported.On (b)(6) 2025 an additional clip was implanted lateral to the slda.There was no clinically significant delay.

• Brand Name: MITRACLIP
• Common Device Name: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23328643
• Report Number: 2135147-2025-05974
• Device Sequence Number: 10612423
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: (01)08717648230967(17)220311(10)10312R153
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2022
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 10312R153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male